Celgene Corporation - [2012] APO 12

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Celgene Corporation [2012] APO 12

Patent Application: 2011100687

Title:A method of treating a patient

Patent Applicant:  Celgene Corporation
Delegate:  Dr S.D.Barker
Decision Date:  17 January 2012
Hearing Date:  28 November 2011, in Melbourne
Catchwords:  PATENTS – examiner objections –lack of novelty as a “prescription approval code” is considered to be the same as a “prescription approval” – lack of innovative step – claims directed to a method of dispensing thalidomide are not a manner of manufacture – claims to a method including the step of administering thalidomide would not be a manner of manufacture as the essence of the invention does not lie in the useful arts – opportunity to amend

Representation: Patentee: Mr Warwick Rothnie of counsel, assisted by Mr James Cherry, patent attorney of Freehills Patent & Trade Mark Attorneys

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2011100687

Title:A method of treating a patient

Patent Applicant: Celgene Corporation
Date of Decision: 17 January 2012
DECISION
Three grounds for revocation have been made out.

The invention of claims 1 and 3 – 5 lacks novelty.

The invention of claims 1 – 5 lacks innovative step.

The invention of claims 1 – 5 is not a manner of manufacture.

I allow the patentee the remainder of the period for certification to propose amendments to remove the grounds for revocation.
REASONS FOR DECISION

Innovation patent 2011100687 (the patent) was filed by Celgene Corporation on 7 June 2011. The patent was sealed on 30 June 2011. The patent is a divisional application from innovation patent 2010101328 (the parent patent), which itself is a divisional application from innovation patent 2010100294 (the grandparent patent). Both the parent and grandparent patents ceased under section 143A due to failure to gain certification within the time prescribed by regulation 9A.4.
The Commissioner decided that it was appropriate to commence examination of the patent pursuant to section 101A, and an examination report issued on 29 August 2011. That report raised grounds for revocation that had been raised during examination of the parent and grandparent patents. The examiner issued two further reports in response to submissions and proposed amendments provided by the patentee. The Commissioner decided that it was appropriate to set the matter for hearing, and the patentee requested to be heard orally. A hearing was conducted on 28 November 2011 in Melbourne. The patentee was represented by Mr Warwick Rothnie of counsel, and Mr James Cherry, patent attorney with Freehills Patent & Trade Mark Attorneys.
1 The patent
The patent is titled “A method of treating a patient”. The specification states that some pharmaceuticals with useful activity are known to have adverse side effects in some members of the population. Thalidomide is known to cause birth defects, but also has useful activity in the treatment of erythema nodosum leprosum (ENL). The essence of the patent is summarised in the Abstract filed with the specification on 7 June 2011:
“The present invention relates to improved methods for delivering a drug such as thalidomide…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

Continue reading Celgene Corporation

Details

AGLC: Celgene Corporation [2012] APO 12
Case: [2012] APO 12
Decision Date: 17 January 2012

CaseChat Overview and Summary

Celgene Corporation is the patent applicant for a method of treating a patient by permitting a prescription for thalidomide to be filled by a pharmacy only after a prescription approval code has been communicated to the pharmacy to authorise the dispensing of thalidomide to the patient. The applicant filed the patent application on 7 June 2011. The Commissioner of Patents issued an examination report on 29 August 2011 raising objections that the invention lacks novelty, lacks innovative step and is not a manner of manufacture. The patentee requested to be heard orally and a hearing was conducted on 28 November 2011 in Melbourne. The patentee was represented by Mr Warwick Rothnie of counsel, and Mr James Cherry, patent attorney with Freehills Patent & Trade Mark Attorneys.

The court found that the invention of claims 1 and 3 – 5 lacks novelty as they are anticipated by US patent application 2007/0219825. The court found that the invention of claims 1 – 5 lacks innovative step as there is no substantial contribution to the working of the invention. The court found that the invention of claims 1 – 5 is not a manner of manufacture as the essence of the invention does not lie in the useful arts. The court found that three grounds for revocation have been made out and revoked the patent.

The court allowed the patentee the remainder of the period for certification to propose amendments to remove the grounds for revocation. However, any amendments must meet the normal allowability criteria of section 102. The court did not make any final orders in this decision.

Orders